What if you have two medical devices with their own CE marking but they are combined and used together - how would this product be regulated in Europe? The assembly is referred to as a “system” or “procedure pack”. Article 12 of the Medical Devices Directive (MDD) 93/42/EEC defines the conformity assessment necessary to configure individual medical devices into a system.
In this whitepaper, we discuss the regulations and requirements to market you products as a system in Europe. You will learn:
- What are the requirements of Article 12?
- What are the system assembler responsibilities?
- What does it mean to verify mutual compatibility?
- How to package your system and supply relevant information?
- How to declare internal control and inspection?
We'll answer all these questions and mor ein this 4-page white paper.
About the Author:
Jennifer Tribbett is a Senior Regulatory Consultant for Emergo, based in Austin, Texas.